← Back to Search

Kinase Inhibitor

Savolitinib/Savolitinib+Fluvoxamine for Healthy Male Subjects

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up period 1: day 1 to day 3 and period 2: day 5 to day 7

Awards & highlights

Study Summary

This trial will study how a drug (fluvoxamine) affects another drug (savolitinib) in healthy male volunteers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ period 1: day 1 to day 3 and period 2: day 5 to day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~period 1: day 1 to day 3 and period 2: day 5 to day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and period 1: day 1 to day 3 and period 2: day 5 to day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under plasma concentration time curve from zero to infinity (AUCinf) for savolitinib

Maximum observed plasma (peak) drug concentration (Cmax) for savolitinib

Secondary outcome measures

AUCinf for metabolites M2 and M3

AUClast for metabolites M2 and M3

Apparent total body clearance of drug from plasma after extravascular administration (CL/F) for savolitinib

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Savolitinib/Savolitinib+FluvoxamineExperimental Treatment2 Interventions

In period 1, subjects will receive a single oral dose of savolitinib on Day 1 after overnight fasting. Following minimum 10 days of washout after the last dose of savolitinib, in period 2 subjects will take oral doses of fluvoxamine alone, twice daily from Days 1 to 4. On Day 5 subject will receive a single oral dose of savolitinib and a twice daily oral dose of fluvoxamine. On Day 6, subjects will receive a twice daily oral dose of fluvoxamine alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluvoxamine

2020

Completed Phase 4

~3259230

Savolitinib

2019

Completed Phase 1

~110

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor

303 Previous Clinical Trials

100,810 Total Patients Enrolled

1 Trials studying Healthy Male Subjects

6 Patients Enrolled for Healthy Male Subjects

AstraZenecaLead Sponsor

4,265 Previous Clinical Trials

288,605,266 Total Patients Enrolled

3 Trials studying Healthy Male Subjects

102 Patients Enrolled for Healthy Male Subjects

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age of 40 supersede participation criteria for this study?

"This trial is seeking individuals aged 18-55 to participate."

Answered by AI

What adverse effects could be experienced by individuals taking Savolitinib/Savolitinib+Fluvoxamine?

"Due to the limited information available on Savolitinib/Savolitinib+Fluvoxamine, our team at Power has assessed its safety as a 1. This is consistent with it being in Phase 1 of clinical trials where efficacy and safety are still unconfirmed."

Answered by AI

Are there still opportunities for participants to enroll in this research?

"According to clinicaltrials.gov, this particular medical trial has stopped recruiting patients since May 25th 2023 - it initially opened up on June 15th of the same year. However, there are presently 10 other trials that are actively seeking participants."

Answered by AI

How can I become involved in this medical experiment?

"To be part of this medical investigation, participants must meet the criteria for healthy male subjects aged 18 to 55. The trial has space for 16 qualified candidates."

Answered by AI

What primary objectives will this research endeavor attempt to accomplish?

"This clinical trial's focus will be to measure the Area under plasma concentration time curve from zero to infinity (AUCinf) for savolitinib over two distinct periods. Secondary objectives include evaluating AUClast, Cmax and AUCinf of metabolites M2 and M3 when administered alone or with fluvoxamine during Period 1: Day 1-Day 3 and Period 2: Day 5 - Day 7."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects

2023. "A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05888207.